A new report from a European generics trade association says that extreme cost-containment policies can adversely affect the generics supply chain vide consolidation of generics drug production and withdrawal of such products from the market.
- February 4, 2022 Pharmaceuticals, Regulatory Affairs
- February 3, 2022 Biologicals, Pharmaceuticals
Over time, there have been huge developments in medicines and biologics sectors, and so have the changes in their respective Regulatory regimes and manufacturers’ responsibilities. On similar lines, recently, the TGA issued guidance describing the responsibilities of manufacturers of medicines and biologics. It is a step-by-step guide for:
- January 27, 2022 Medical Devices
The Medical Device industry is booming, with new technologies emerging every other day. The year 2021, like 2020, has experienced continued disruption owing to subsequent waves of the COVID-19 pandemic. However, the MedTech industry and its regulations have been changing steadily and adapted to all the changes swiftly to ensure all requirements laid down by the Agencies are met within timelines.
- January 7, 2022 Regulatory Software & Services
The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape.
Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business.
It is apparent that COVID-19 has permanently changed the ways of business operations for many industries across the globe. In fact, it has subtly given a renewed purpose to industries to evolve and advance in terms of tech-enabled and automated workflows.
- December 20, 2021 Medical Devices
The FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022.
- December 20, 2021 Medical Devices
It is well-known that Unique Device Identification (UDI) is critical, and if implemented accurately, it will garner major and long-term benefits for medical device manufacturers, healthcare providers, and consumers.
- December 17, 2021 Medical Devices
A 510(k) submission for medical devices is a mandatory process to receive market clearance in the USA. While the submission process may not be onerous, figuring out where and how to begin can be daunting. However, the US FDA provides ample information in its guidance documents to assist the medical device manufacturers for a smooth 510(k) submission.
- December 17, 2021 Medical Devices
Intending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.